Device and method to monitor, track, map, and analyze usage of metered-dose inhalers in real-time

ABSTRACT

A system and method for accurately and reliably determining and recording the time, date and location where a medication is used, and a system and method for transmitting, collecting, and using that data to improve clinical care, disease management, and public health surveillance. The device allows information concerning drug usage, including the time, date and location of use, to be transmitted to a remote network computer system so that the data can be evaluated to determine current impairment and future risk, and to identify changes in the frequency, timing, or location of medication usage indicative of change in disease control or management, and to examine spatial, temporal or demographic patterns of medication use or absence of use among individuals and groups. In addition, the device may further be configured to transmit signals indicative of its status, condition or other results to the remote network computer system.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/364,174 filed on Nov. 29, 2016, which is a continuation of U.S.patent application Ser. No. 12/348,424, filed on Jan. 5, 2009, now U.S.Pat. No. 9,550,031, which claims priority from U.S. Provisional PatentApplication No. 61/025,511, filed on Feb. 1, 2008. The foregoingapplications are hereby incorporated by reference in their entirety forall purposes.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to inhalers. More specifically,the present invention relates to a device and method for tracking andanalyzing the location, timing and frequency of usage of medicationinhalers, such as those used to treat asthma, chronic obstructivepulmonary disease, and other medical conditions.

BACKGROUND OF THE INVENTION

Asthma remains a significant and costly public health problem. In theUnited States, more than 22 million people have the disease; worldwide,the World Health Organization estimates the population with asthma maybe 300 million, and predicts that it will rise to 400 million by 2025.

Despite the development of new medications, rates of hospitalizationsand emergency room visits have not declined. Each year in the UnitedStates the disease causes approximately 2 million emergency departmentvisits, 500,000 hospitalizations, and 5,000 deaths. In addition, asthmais responsible for an estimated 15 million missed days of school, and 12million days of work. Total annual costs to US health insurers andemployers are greater than $18 billion.

The majority of these exacerbations could be prevented with currentlyavailable treatments, however, only 1 in 5 asthmatics has the diseaseunder control. Newly revised national guidelines urge doctors to moreclosely monitor whether treatment is controlling everyday symptoms andimproving quality of life. Physicians, however, have few available toolsto assess how well their patients are doing day-to-day. An increasingnumber of physicians have begun to use periodic, written questionnaires(such as the Asthma Control Test) to monitor patients and determinetheir level of control. These instruments require patients to accuratelyrecall and report the frequency of symptoms, inhaler usage, and activitylevel and restriction over some period of time (usually two to fourweeks). As a result, these questionnaires are subject to errorintroduced by biases (recall), different interpretations of symptoms,and behaviors (non-adherence), and only provide information at the timethey are used.

Nearly all persons with asthma carry an inhaled medication toimmediately relieve symptoms wherever they occur. The frequency withwhich patients use these medications is one of the most importantindicators of how well their disease is controlled. Physicians who couldremotely monitor the use of these medications by patients in real-timewould be able to identify and help patients in need of additionalattention before they suffer an exacerbation.

Asthma is unique in that important medication(s) are often used at thelocation and time of exposures that cause exacerbations. Manyexacerbations are caused by exposure to environmental factors such asallergens, air pollutants, tobacco smoke, and occupational chemicals,but identifying causative exposures or locations that pose a particularthreat has been a struggle for public health experts.

Since established risk factors do not explain the prevalence of asthmaor its trends over time, it is likely that there are unknownenvironmental factors that trigger symptoms or contribute to thedevelopment of asthma.

Public health officials have been limited to the retrospective analysisof the small proportion of attacks that led to emergency room visits andhospitalizations (the most severe exacerbations). These events indicatewhere the patient lives or the location of the health facility wherethey received treatment, but provide no information about where theirexacerbation began. Last year, the US Centers for Disease Control andPrevention recommended that the timeliness and geographic specificity ofasthma surveillance data be improved.

As a result, real-time tracking and mapping of the locations wherepersons with asthma use their inhaled medications would improvescientific assessment and management of asthma, and enable better publichealth surveillance of asthma and its relationship to environmentalexposures. Studies of epidemic asthma have demonstrated thatunderstanding the locations where asthma exacerbations occur can helpidentify important new exposures.

In addition, many patients with asthma triggered by exposures at schoolor work do not recognize the relationship between their symptoms andspecific locations, resulting in missed opportunities to avoid ormitigate the exposure and thereby prevent further exacerbations.

At present, there are no commercially available devices that allow thelocation where an inhaler is used to be objectively obtained. Inaddition, there are no commercially available devices that allowphysicians to monitor the medication use of their patients in real time,to gauge their control over the disease, and to use technology todetermine who needs additional attention. Furthermore, there are nosystems that allow public health officials to collect and analyze dataon the medication use of individual patients in order to monitor in realtime the overall burden of the disease in the community or to guidepublic health interventions and epidemiological research.

Various systems have been proposed to record the time and date of usageof metered dose inhalers. Two models are currently available in the U.S.market. One device, described in U.S. Pat. No. 5,505,192, attaches tothe end of a metered dose inhaler and records the time and date ofinhaler use over a 30 day time period. Another device, described in U.S.Pat. No. 6,202,642, captures the time and date of inhaler use, andprovides a means to transmit this information at a later time to thehealth care provider. To accomplish this, the patient must connect theirdevice to a computer.

Several devices that provide means for the two-way transmission ofinformation between a medication and a remote network using wirelesstechnologies have also been proposed. U.S. Pat. No. 6,958,691 describesan inhaler having an electronic data management and display system and acommunicator for wireless communication with a network computer system.U.S. application 2006/0089545 proposes use of a cellular phone totransmit information about medication, and to present medicationinformation and treatment instructions to the patient.

The primary aim of both of these devices is to encourage and improvepatient compliance with their prescribed medication regimen. As aresult, these systems focus on providing education (treatmentinstructions), monitoring, and supervision. In addition, the abovedevices provide for two-way communication between the inhaler (ordevice) and the physician or health care provider, and some allow forcontrolling or modifying the medication delivered by the inhaler (seeU.S. Pat. No. 5,477,849).

Various methods for the epidemiological analysis of medical data andinformation (such as emergency room visits or hospitalizations, or overthe counter medication purchases) have been proposed. However, thesesystems are focused on establishing a diagnosis or on tracking andanalyzing the geographic location(s) of health care utilization (such asemergency room visits or hospitalizations) or the residence of theperson with the disease of interest. No known system describes theanalysis of the location where the medication is used, or proposes asystem for aggregating and making use of information from a populationof individuals.

SUMMARY OF THE INVENTION

The present invention comprises a device that, when attached to ametered dose inhaler, or other medication or medical device, determinesthe location, time, and date when the medication or medical device isused, and communicates that information to a remote network computersystem. The device includes supporting electronics (microprocessor,memory, etc.), an electronic data management system, a use sensor, acommunication device, antenna(s), and a battery. The device is capableof wireless communication with a network computer system to enablecommunication of data between the electronic data management system andthe network computer system.

In a first embodiment, the device uses a terminal device, such as acellular phone, and the in-built capabilities of the terminal deviceand/or its associated network, to determine its location and to transmitinformation about the time and location the medication is used to thenetwork computer system.

In another embodiment, the device utilizes an autonomous globalpositioning system receiver and a communication device to wirelesslycommunicate the geographic position and time and date of use directly toa network computer system.

In either embodiment, the present invention comprises a collection ofsoftware applications running on the network computer system thatreceive, analyze, and display the collected data in online interfaces,and provide means for a wide variety of operations.

For example, used together, the system, the device, and the onlineinterfaces generate real-time displays and maps of asthma medicationuse; collect and deliver information on the use of inhaled medicationsto inform and guide management of the disease; perform statisticalanalyses to identify spatiotemporal clusters and temporal aberrations;and deliver alerts to authorized users, such as the patient and thepatient's health care providers.

By providing information about the timing and frequency of use of themedication or medical device, and identifying the geographic locationwhere an individual uses their medication or medical device, the systemmay facilitate better management of a variety of diseases by the patientand their health care provider, and improve recognition of specificlocations (such as workplace, school, or home, among others) thatprecipitate exacerbations in order that the patient may avoid or modifythese locations to prevent future exacerbations.

By aggregating and analyzing the aggregated information about thetemporal patterns and geographic locations of individual patterns ofmedication use, the device and method provide public health andenvironmental health agencies with a real-time means to (A) identifyclusters of exacerbations, (B) assess the burden of disease in apopulation or some portion of the population, and in some geographicarea, (C) plan and evaluate public health interventions to reducemorbidity, and (D) detect new epidemiological patterns or risk factors.

The invention includes both the monitoring system and the methods bywhich the device and system are utilized by patients, health careproviders, scientists and researchers, and public and environmentalhealth agencies, among others.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and form a partof the specification, illustrate the present invention and, togetherwith the description, further serve to explain the principles of theinvention and to enable a person skilled in the pertinent art to makeand use the invention.

FIG. 1 is a schematic outlining a complete system for monitoringmedication use by a patient;

FIGS. 2a, 2b, 2c, and 2d are schematic diagrams of the medicament devicein the first and alternative embodiments;

FIG. 3 is a schematic diagram illustrating the flow of information onthe medicament device and the terminal device (if used) in the first andalternative embodiments; and

FIG. 4 is a schematic diagram outlining the software applications andthe flow of information on the network computer system.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description of the invention and of exemplaryembodiments of the invention, reference is made to the accompanyingdrawings (where like numbers represent like elements), which form a parthereof, and in which is shown by way of illustration specific exemplaryembodiments in which the invention may be practiced. These embodimentsare described in sufficient detail to enable those skilled in the art topractice the invention, but other embodiments may be utilized andlogical, mechanical, electrical, and other changes may be made withoutdeparting from the scope of the present invention. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present invention is defined only by the appendedclaims.

In the following description, numerous specific details are set forth toprovide a thorough understanding of the invention. However, it isunderstood that the invention may be practiced without these specificdetails. In other instances, well-known structures and techniques knownto one of ordinary skill in the art have not been shown in detail inorder not to obscure the invention.

Referring to the Figures, it is possible to see the various majorelements constituting the apparatus of the present invention. Thepresent invention provides a system and method for reliably determiningand recording the time, date, and location where a metered dose inhaleris used and a system and method for transmitting, collecting, and usingthat data to improve clinical care, disease management, and publichealth surveillance.

FIG. 1 illustrates the overall flow of information 100 from a medicamentdevice 101 attached to an inhaler, to the terminal device 102 (if used),to a wireless communication network 103 (if used), to a remote networkcomputer system or server 104, and finally an online interface 105 foruse by one or more users 106.

FIGS. 2a, 2b, 2c and 2d show schematic diagrams of the first andalternative embodiments of the medicament device shown in FIG. 1 thatare suitable for use in a system according to the present invention. Thedevice is attached to the medicament dispenser or housing 207, andcontains a medication canister 201, a cap or collar or tag or label 202,a communication device 203, supporting electronics 204, a power supply205, an actuation detector 206, and in an alternative embodiment, aglobal positioning system receiver 208.

The medicament device is mechanically coupled to the medicamentdispenser 207 containing the medication canister 201 and suitablyattached to the medication canister 201 by any suitable mechanicalmechanism including grip mechanisms, snap-fit mechanisms, strap(s),clamp(s), and adhesive fixing. The unit may, for example, form asnap-fit module that is received or is receivable by the medicamenthousing 207 shown in FIG. 2a , or may be mounted on the top of themedication canister 201 by mechanical means shown in FIG. 2b . In eitherembodiment, the medicament device is simple to install, attachessecurely, is easily removed and transferable to replacement medicamentdispensers, fits numerous dispensers, and is compatible with allapplications. In aspects, the medicament device or any distinct deviceaspects of the system may be adapted to be worn on the body of the user.Examples would include belt-attachable devices, and devices in the formof watches for wrist or leg attachment.

The system additionally comprises a detector for detecting dispensingfrom the medicament container, or a means for obtaining informationrelated to the dispensing of the medication. The means may be a usesensor or a detector for detecting movements, for example, theactivation of the dispensing mechanism. The use sensor is essentially aswitch, the main characteristic of which is that it should close anelectrical circuit when the drug is delivered and, as a result, send asignal to the microprocessor of the device. The dispenser monitoringsystem is operationally transparent to the user in that it monitors eachdose automatically upon actuation of the dispenser without anyadditional action on the part of the user.

In the first embodiment, the sensing is achieved by an actuationdetector 206 including an miniature magnet and a magnetic field sensor.The miniature magnet of the actuation detector 206 is integrated into acap or collar 202, which is mounted to the top of the medicationcanister 201. A magnetic field sensor of the actuation detector 206 isthen housed within or on the stationary body of the medicament device.When the user actuates the inhaler canister, the canister is depressed,and the magnet is carried toward the magnetic sensor. When the magnet isbrought in proximity to the magnetic sensor, the sensor acts as amagnetically actuated switch causing a voltage output change in thesensor, which is recorded. In one embodiment, a bounce filter circuitelement, composed of, for example, a charging capacitor and a thresholddetector, is installed in order to eliminate the possible effect ofextra bounce pulses resulting from bouncing or vibration of thecanister.

Other suitable techniques for the actuation sensor switch includedetectors using detection of capacitive or thermodynamic effects,optical detectors, or mechanical levers, among others.

For example, in another embodiment shown in FIG. 2b , the device isentirely contained in a package mounted on the end of the medicationcanister 201. A mechanical switch 216 integrated into the package,consisting of, for example, a spring-loaded lever, force sensingresistor or contact rod, monitors the dispensing of the medication andis mechanically depressed or electrically actuated in response to thedownward movement of the medication canister 201.

In another embodiment shown in FIG. 2c , similar switch mechanisms areintegrated into a cap mounted onto the medication container 201 andconnected by leads to the medicament device, which is attached to theside of the medication housing 207. The actuation detector 206 includesa momentary push button switch surrounded by a spring 211 and discs 212.When the user actuates the inhaler canister, the cap and canister aredepressed, compressing the discs and spring and closing the switchcircuit signaling actuation of the inhaler. The tension of the spring211 is set to preclude accidental actuation of the switch circuit, whenno actuation of the inhaler occurs or is intended.

In another embodiment shown in FIG. 2d , a small tag or label 210containing a pattern is attached or fixed atop the medication canister201, by any suitable means including adhesive fixing, grip mechanism,snap-fit arrangements or through the use of various mounting means. Themounting means may, for example, comprise an adhesive label, wrap-aroundtape, or cap or collar arrangements. The actuation detector 206 includesan optical sensor on the medicament device that monitors the tag orlabel on the canister. Each time the medication canister 201 isdepressed, the optical sensor image of the pattern is disrupted, andactuation of the inhalation device is signaled to the controller.

In another embodiment, the switch is integrated into the medicamentdevice itself, with a contact lever extending out the back of the devicepackaging into the area above the top of the medicament dispenser orhousing 207. When the medication canister 201 is depressed, a cap 202mounted to the top of the medication canister 201 contacts the switchand an actuation is detected.

In another embodiment, electrical contacts integrated into a cap 202mounted on the end of the medication canister 201 meet correspondingelectrical contacts on the device when the canister is depressed,closing a circuit.

In another embodiment, a lever or other element extends into thehousing, and is positioned for movement each time the medicationcanister 201 is pushed downwards. Movement of the lever actuates amicro-switch on the controller indicating that the inhaler has beenactuated.

In another embodiment, a mechanical switch is integrated into a cap orcollar 202 that is mounted onto the top of the medication canister 201.The switch consists of a spring-loaded lever that is mechanicallydepressed by the body of the medicament device, the medicament dispenseror housing 207, or a collar around the housing by the downward movementof the canister 201 when it is actuated.

In another embodiment, a thermistor or similar sensor is used to measurethe change in the temperature of the pressurized medication canister 201resulting from the expulsion of medication and propellant. In the caseof a thermistor, a typical circuit puts a constant current through thethermistor and measures the variation in voltage resulting from anychange in the temperature of the medication canister 201. Each time theinhaler is actuated, the temperature of the canister 201 is temporarilydecreased relative to its temperature prior to usage; this change isdetected by the thermistor and the actuation of the inhaler is signaledto the controller 204.

Furthermore, the support electronics 204 arranged on the medicamentdevice comprise a microprocessor and memory for storage of informationrelated to the medication events. The memory comprises a non-volatilememory chip that is capable of storing the information, for example,when the transfer of data from the medicament device and the terminaldevice is disturbed, or during a predetermined period of time.

Preferably, the memory includes random-access memory such as a DRAM(dynamic random access memory) or SRAM (static random access memory),and nonvolatile memory such as an EEPROM (electrically erasableprogrammable read-only memory). The EEPROM can be used to store softwareprograms executed by the microprocessor, such as software that controlsthe operation of the medicament device. In addition, the EEPROM allowsthe stored software programs to be remotely updated.

The medicament device is also provided with a power source 205 so as topower the electrical components. A suitable power source 205 is abattery, clockwork energy store, solar cell, fuel cell orkinetics-driven cell. The power source 205 may be arranged to berechargeable or re-loadable.

In addition, the medicament device support electronics 204 may be fittedwith light elements, for example, one or more diodes, or speakers. Themedicament device can thereby provide a visual or audible indicationwhen the battery capacity has reached a certain predetermined capacitylevel and/or provide a warning that it needs to be recharged. Otherdiode(s) can be arranged to provide a visual indication that anactuation has occurred, and that the message from the medicament deviceto a terminal device, the wireless communication network, or the networkcomputer system, has or has not been transferred successfully.

Moreover, a communication device 203 for wireless communication with aterminal device 102, such as a cellular phone, a wireless communicationnetwork 103, and/or a network computer system 104, to enable transfer ofdata to and from the medicament device is arranged in the medicamentdevice. The communication device 203 includes, inter alia, a transceiverand an antenna 209, and an embedded network server, or equivalent fortransmitting or receiving data or the outcome of an operation on thedata.

Moreover, the communication device 203 may be arranged for two-waytransfer of information. Accordingly, a terminal device 102 or thewireless communication network 103 or the network computer system 104can, in addition to receiving information from the communication device203, transfer information to the communication device 203, for example,a packet to acknowledge receipt upon a successful transfer ofinformation from the medicament device.

The so-enabled device may also have the capability to form local areanetworks with other similarly enabled devices to enable local transferof data there between.

In one embodiment, the communication device 203 communicates with aterminal device 102 using radio frequency signals, for example,spread-spectrum radio frequency signals. A suitable spread-spectrumprotocol is the BLUETOOTH standard that employs rapid (e.g. 1600 times asecond) hopping between plural frequencies (e.g. 79 differentfrequencies). The protocol may further employ multiple sending of databits (e.g. sending in triplicate) to reduce the effect of interference.Of course, the communication device 203 can use other means tocommunicate with a terminal device 102, for example, optical signals.

In another embodiment, the medicament device 101 uses the communicationdevice 203 to directly access a wireless communication network or aprivate or public network computer system as shown in FIG. 3, includingone or ones that may also form part of a telecommunications system,which may itself be either a traditional copper wire system, a cellularsystem or an optical or microwave network, wireless metropolitan areanetworks (WMAN), broadband fixed access (BWA), wireless networks, suchas wireless application protocol (WAP), 802.11 wireless LAN (WLAN),long-range RF networks, satellite networks, and distributed sensornetworks (including stationary and dynamic), among others. Othersuitable wireless communication mediums/methods include wireless digitaldata networks, two-way paging networks, specialized mobile radiosystems, infrared, and non-licensed ISM-service communication links,such as the BLUETOOTH protocol. Further communication methods includeInternet protocol (IP) addressing, among many others.

As a result, the communication device 203 may comprise an embeddednetwork server to enable it to communicate directly with a networksystem, typically using Internet Protocol. The embedded network serverwill have hardware and software components and for example comprise anHTTP (web) server, an FTP (file) server or an SMTP (main) server. Theembedded network server will typically be provided with a unique networkaddress including an IP address, a website address, an e-mail address,or a file transfer protocol address.

The Internet is one suitable example of a public access network computersystem, wherein the point of access thereto can be any suitableentry-point including an entry-point managed by an internet serviceprovider. The public access network may also form part of atelecommunications system, which may itself be either a cellular systemor an optical network or some other radio frequency signal network. Inthis embodiment, the network computer system comprises a public accessnetwork computer server system and a private access network systemcomprising for example, an Intranet or Ethernet which may, for example,be maintained by an individual, a municipality, a commercial entity, ahealthcare provider, a service provider, a pharmacy, or a universitymedical center. Accordingly, the medicament device can communicate withone or more third parties, such as medical centers, healthcareproviders, and other suppliers of healthcare products and servicesdirectly via the wireless communication system and the network computersystem.

The medicament device 101 may therefore transmit and/or receiveinformation to and from the network computer system 104 by means of aterminal device 102, a wireless communication network 103, and to thenetwork computer system 104 directly, and between any and all of thesemeans in any sequence.

The medicament device is configured to transmit various information overthe network, such as the location, time, and date of medication events,the status or condition of the medical device (battery level, etc.) orthe medication, self-test results, or even physiological data of apatient being treated with the medicament device.

This feature allows a remote operator to not only identify the time andlocation of the medicament device when it is used, but also to monitorthe medicament device itself or events occurring in association with themedicament device at the remote site.

Of course, there are other conceivable types of medications and medicaldevices that are suitable for use in the system according to the presentinvention such as dry powder inhalers, and portable or stationarynebulizers, peak flow meters or spirometers, injectors, tabletdispensers, and medical devices such as blood pressure monitors, bloodglucose monitors, canes, walkers, and pedometers.

In addition, examples of conditions that would be suitable formonitoring include asthma or chronic obstructive pulmonary disease,cystic fibrosis, non-cystic fibrosis bronchiectasis, forms ofinterstitial lung disease, reactive airways disease, occupational lungdisease, and patients having fluctuations in congestive heart failurecontrol. Because of the frequency of lung involvement, these deviceswill also be useful in the treatment and monitoring of patients afterlung (or other solid organ) transplant or bone marrow transplant.

Referring now to FIG. 3, a block diagram of the flow of medication eventinformation through the system 300. After the actuation detector 206observes a medication event, an application is run by themicrocontroller unit (MCU 301) which obtains information related to themedication. To this end, the means for obtaining information constantlymonitors the dispensing of medication in order to register events, orthe absence of events, related to the dispensing of the medication. Amedication event may be, for example, that the patient using themedicament device dispenses the medication or fails to dispense themedication.

The information related to the medication event or events can be storedin the memory (as described above) of the medicament device ortransferred to the network computer system either directly, or via awireless communication network, or via a terminal device.

The information is then processed by a BLUETOOTH profile stack 302 andtransferred to the communication device 303. Then the information iswirelessly transferred or sent via a wireless antenna 306 to thewireless antenna of a terminal device 307 or directly to the networkcomputer system 304 through a wireless network antenna or access point305.

In case of disturbances or the like of the information transfer, or if alink could not be established between the communication device 303 andthe terminal device or the network computer system 304, preventing thecommunication device 303 from transferring the information to thenetwork computer system 304 or the wireless receiving antenna of theterminal device 307 by a wireless antenna 306, the information may bestored in the memory of the medicament device, as mentioned above.

Thereafter, when a connection is established, the information can besent or transferred to the terminal device or the network computersystem 304.

When the terminal device receives the information through a BLUETOOTHradio 308, an acknowledgment receipt is transmitted back to themedicament device. Preferably, the user is notified by means includinglight (diode) means on the medicament device, as mentioned above. Othermeans may include audible signals, visualizing means, or vibrationmeans. At this step, the medicament device performs any final processingand returns itself to its idle state, in order to minimize powerconsumption.

In the first embodiment, the terminal device is a cellular phone. Ofcourse, there are other types of terminal devices that are suitable foruse in the system according to the present invention, that have acommunicator means and provide means to connect to and transmit data toa network computer system, including but not limited to pagers, modems,computers, portable music players, wristwatches, automobiles andvehicles, global positioning receivers and personal navigators,electronic medical devices, or other portable electronic devices.

In one embodiment, the terminal device contains a global positioningsystem (GPS) receiver and processor, which relies on the use of multiplecommunications signals and a triangulation algorithm.

An application on the terminal device monitors a communication port todetermine when a message was received from the communication device 303in the medicament device and processed by the BLUETOOTH profile stack309. Upon receiving the message, the terminal device applicationgenerates a time stamp and processes the information by the operatingsystem stack of the cellular phone 310 and a software applicationrunning on the cellular phone. The processing means of the terminaldevice determines the location of the terminal device at the time ofreceipt of the medication event information using the available means.Preferably, the geographic coordinates can be calculated locally from aglobal positioning system receiver and processor 313 in the terminaldevice. In that case, the terminal device application retrieves thenecessary information and processes it.

Alternatively, the determination of location information may beaccomplished using network-based technologies or solutions, wherein thelocation of the medicament device and/or the terminal device isidentified based on a communication link connecting the medicamentdevice and/or the terminal device with a remote locating service overthe network. For example, certain cellular phone systems track thestrength, the angle, and the arrival time difference of transmissionsignals for determining a cell phone location, using time difference ofarrival technology or timing advance location measurement technology. Inthis embodiment, the overall communication network, perhaps at its basestation, identifies the location of the device and the identifiedlocation may or may not be of the medicament device or the terminaldevice is determined by reference to the known location of wireless datanetworks that are within the range of the device. If the medicamentdevice or terminal device or wireless carrier requires that geographiclocation data be obtained from the wireless network provider then theappropriate steps are taken to obtain the geographic coordinates of themedicament device or the terminal device from the network of thedesignated provider.

Further alternatively, the location determination may be based on acombination of both handset-based technologies and network-basedtechnologies. Using a combination of location identification systemsallows the reliable identification of the location of the medicamentdevice and/or the terminal device, even when these devices are placed inunfavorable locations, such as within buildings or urban canyons whereglobal positioning technologies may not function accurately or reliably,or in rural areas where network-based technologies may functionunfavorably.

Accordingly, the system refers to any system that can determine thelocation of an object, regardless of the particular technologies used todo so and therefore is intended to encompass all such capable systemsapplied in various networks in various countries. For example, thesystem encompasses the location identification capability in thewireless Enhanced 911 standard prescribed by the United States FederalCommunications Commission (the wireless E911 standard). The wirelessE911 standard mandates that cellular phone service providers within theUnited States provide the capability to locate the position of acellular phone making an emergency (911) call within the provider'ssystem. The determination of location information encompasses suchlocation identification capability as applied to all calls placed to anynumbers, not limited to emergency calls nor limited to calls placed onlyin the United States.

Once the location and time data has been received and processed, theterminal device application formats the time and location informationinto a message and prepares it for transmission 311 through the wirelesscommunication system of the cellular phone. The terminal device isconnected to a network computer system via a wireless antenna 312 fortwo-way transfer of data between the terminal device and a networkcomputer system 304.

The wireless communication system utilizes any one of a variety ofwireless communication mediums and/or communication methods to transferdata. Examples include, but are not limited to, wireless telephony,including analog cellular, digital personal communication service (PCS),short message service (SMS), wireless application protocol (WAP),wireless metropolitan area networks (WMAN), and broadband fixed access(BWA), among others. Other suitable wireless communicationmediums/methods include wireless digital data networks, such as 802.11wireless LAN (WLAN), two-way paging networks, specialized mobile radiosystems, infrared, and non-licensed ISM-service communication link, suchas the BLUETOOTH protocol. Further wireless communication methodsinclude Internet protocol (IP) addressing.

Accordingly, the wireless data communicator can be any device thatcommunicates with the chosen wireless communication network through awireless channel. For example, the wireless data communicator may be acellular phone, pager, personal digital assistant, PCS handset, orpersonal computer. The wireless communication network may also include anetwork that is in part a wired network. For example, the wirelesscommunication network may include the standard Public Switched TelephoneNetwork (PSTN) with which the wireless data communicator interfaces.

The Internet is one suitable example of a public access network computersystem, wherein the point of access thereto can be any suitableentry-point including an entry-point managed by an internet serviceprovider. The public access network may also form part of atelecommunications system, which may itself be either a cellular systemor an optical network or some other radio frequency signal network. Inthis embodiment, the network computer system comprises a public accessnetwork computer server system and a private access network systemcomprising for example, an Intranet or Ethernet which may, for example,be maintained by an individual, a commercial entity, a healthcareprovider, a service provider, a pharmacy, or a university medicalcenter. Accordingly, the terminal device can communicate with one ormore third parties, such as medical centers, healthcare providers, andother suppliers of healthcare products and services via the wirelesscommunication system and the network computer system.

Further, the medicament device and/or the terminal devices may also bearranged to communicate medication event information with othermedicament devices or terminal devices in the local environment, bymeans of their respective communicators, facilitating patient awareness,communication, and appropriate preventive actions as warranted.

The terminal device 102 determines, based on a variety of parameters,the optimum means for transmitting information to the network computersystem 304 and establishes any and all necessary connections. When aconnection between the terminal device and the network computer system304 is established, and the terminal device transmits 311 theinformation about the medication event, as in the case of an eventreferring to dispensing of medication, the location, time and date ofdispensing detected by the medication device, to the network computersystem 304 in one form or another such as, but not limited to, an SMSmessage, an email, an http request, or some other form of data transfer.

FIG. 4 is a schematic diagram outlining the software applications andthe flow of information 400 on the network computer system 304. Incomingdata 401 is stored in a database 403 after undergoing update routines402. The database may also receive information from remote sources 404and other remote network computer systems 405. Database update routines402 are comprised of analytical routines 406 provided by the controlmodule 407. Users 408 must be authenticated 409 to access the systemusing the interface tools and other user interfaces 410 provided by thesystem. The control module 407 executes and supervises the input format411, statistical analysis 412 and output format 413. The input format411 reads data from relevant databases and outputs files necessary forstatistical analysis 412. Statistical analysis 412 performs analyses onfiles and outputs results into files. The output format 413 reformatsthe statistical output and saves the data to separate files to be readby applications. The output format 413 also provides notifications 414to the user interface 410.

In another embodiment shown in FIG. 2d , the medicament device containsa means to autonomously determine its location without use of a terminaldevice. The means may include an built-in global positioning receiverand processor 208 and a transceiver and antenna 209 or equivalent fortransmitting or receiving data, or, as described above, a network-basedmeans or device-based technologies or a combination of both device-basedtechnologies and network-based technologies. In this embodiment, themedicament device identifies its location autonomously as shown in FIG.3, processes the time and date information and the geographicinformation, and uses its built-in wireless communication device 203 tocommunicate this information directly to the network computer system 304or to the network computer system 104 via a wireless communicationnetwork 103.

The network computer server receives the medication event informationtriggering a variety of applications on the remote computer system orserver. An initial set of applications perform a variety of functionsincluding, but not limited, to checking the validity of the incomingdata, passing the verified data to the relevant database(s), andconfirming that the database(s) have been updated.

Next, applications on the server or network computer systemautomatically execute programs to prepare, read, analyze, and displayaccumulated data on medication events. A control application executes aninput formatting application as necessary, which reads relevant datafrom the accumulated database and outputs files necessary for subsequentstatistical analyses. The control program then executes a statisticalanalysis application as necessary, which reads the relevant files andperforms statistical analysis in accordance with user establishedparameters, and outputs or writes the results into separate file(s). Thecontrol program then executes an output formatting application asnecessary, which reformats the statistical results output files into newfiles to be read by applications that display the accumulatedinformation and otherwise make the data available to authorized users.

Further, these applications select the appropriate test statistic(s) oranalytical methods and process the incoming and accumulated data toidentify events of interest. These events may include spatial ortemporal outbreaks or clusters of medication use, or historicallysignificant permutations from individual, geographic, clinical,epidemiologic, demographic, or spatial or temporal baselines orpredicted or expected values. End users may specify, through a varietyof provided tools, the scope and precise parameters of an event. Whensignificant events are detected, the system prepares and deliverselectronic notifications of the events to authorized individuals orgroups, including patients themselves, some or all other patients usingthe system, health departments, health care providers, research teams,emergency medical providers or others. A health care provider, facedwith this information, might, for example, contact the patient toinitiate preventive treatment (including a change of medication, or achange of dosage) or request that the patient visit the clinic or seekemergency medical attention. Notifications provide details, for example,about the timing, location, and affected person(s) or groups involved ornot involved in given event(s). In a further aspect, notifications maybe distributed to an emergency assistance provider, for example ahospital accident and emergency service or an emergency help line orswitchboard. The information may thus comprise a distress or emergencyassist signal that requests emergency assistance.

The messages, notifications and alerts are delivered in one form oranother such as, but not limited to, an SMS message, an email, an httprequest, a phone call, or some other form of alert.

Accompanying online interfaces and applications authorize andauthenticate users. Suitably, different levels of access authorizationto the network computer system will be provided to different authorizedusers. Examples of authorized users may include the patient, a familymember or guardian, a healthcare professional such as a doctor orresearch professional, a database manager, a public health agency, ahealth insurer, a pharmacy or pharmaceutical researcher, and anycombinations thereof.

Online interfaces and tools provide authorized users with the means totrack the patterns and locations of medication usage over a modifiabletime period through an online mapping and visualization systemconsisting of web-based displays, including graphic and geographicvisualizations. The interfaces present a variety of tabular data andgraphical visualizations and analyses of the data collected on thetiming and locations of medication usage.

Further, through the interfaces provided by the network computer system,users can annotate, review, delete, update, and/or otherwise editobservations recorded by the system or otherwise provide or reviseadditional information such as (but not limited to) details about anevent, about disease status (such as level of symptoms), perceivedcauses or triggers of the attacks, medical record information, healthcare utilization, psychological information, environmental exposure, airquality data, traffic data, pollen counts, climatic or meteorologicalinformation, or any other information relevant to disease management,clinical care, public health surveillance and practice, or scientificresearch.

Suitably, a variety of remote information sources may also contributerelevant data, either automatically in accordance with some pre-setalgorithm, or by user instruction, to the network computer system inorder to facilitate additional analyses. For example, a remoteinformation source might be an environmental monitoring station ornetwork of stations that automatically contributes weather, pollencounts and pollution levels, which are thereby made accessible to thesystem.

Further, patient accounts and medication usage data are linked topersonalized instructions from their health care provider, includingsuch information as the parameters and recommendations for when theyshould adjust their medication or seek medical care. The system providesmeans for the two-way transfer of data collected by the system,including the medicament device and the web-based system, to and fromthe patient's medical record(s), pharmacy record, or other electronicmedical information system, such as that maintained by a health careprovider, health care service, health insurer, or public health agency405.

Further, the online interface provides a way for patients to communicatewith other patients—at their discretion—in order to discuss and shareinformation about their disease, medication use, and disease management,among other topics.

Further, the online interface offers the means for patients to provideinformation about the ongoing management of the disease and theirexperience, including, but not limited to, measurements of lungfunction; symptoms; health care utilization; anthropometricmeasurements; physiological measurements including biomarkers such asthose found in exhaled breath or others to be discovered; and othertypes of health assessments or measures including, but not limited to,questionnaires that assess risk factors, level of asthma control, orquality of life, for example.

At the same time, interfaces and applications for authorized andauthenticated physicians, health care providers, researchers and publichealth officials allow them to view, annotate, update, interact with,and export information about patterns of asthma medication use inindividuals, and in various demographic or geographic segments. Usingthe web services, physicians or other authorized parties are able tomonitor patients individually or in aggregate, to set parameters fornotification and disease management guidance (such as compliancereminders), to establish notification thresholds, and to receive visualand statistical feedback on how well their populations or geographicareas of interest or responsibility are doing.

Accordingly, the system can deliver regular reports of usage patternsfor specific demographic groups or areas, over time. In turn, the systemcan feed information, such as compliance information or the location ortiming of medication usage, back to any remote information source 404 orremote network computer system 405 having access to the network computersystem. The system can also be integrated with a healthcare managementsystem.

The system therefore, provides the advantage of enabling data transferwith a network of computers, which can be made accessible to diverseremote information sources 404 and remote network computer systems 405,which may in turn be networked together for cross-transfer of data. Theuser therefore, has ready access to diverse, possibly inter-connected,remote information sources capable of providing a variety of informationpertaining to clinical care, disease management, epidemiological andscientific research, and public health surveillance, among other forms.

Accordingly, the present invention offers several objects andadvantages. It determines the time, date, and geographic location wherethe medication or medical device was used. Thereby, the device allowspatients, family members, health care providers, public healthofficials, and scientific researchers, among others, to focus on thetemporal and geographic correlates (including exposures and locations)that prompt a change in the patient's condition or the use ofmedication.

The device provides a means to transfer information about the use ofmedication (location, time, date) to a network computer system eitherdirectly, or via a variety of terminal devices and/or wirelesscommunication networks.

The device and system provides patients, family members, or health careproviders with a means to monitor, evaluate and analyze patientcompliance with a medication regimen over time.

The device transmits the medication event info in real-time, and, in allembodiments, does not require that the patient, health care provider orany other person participate in obtaining or transmitting the medicationuse information. As a result, it offers an immediate and more accurateand reliable means of assessing medication use compared to existingmethods including dose logging devices, questionnaires in any form, orweb-based interfaces.

Using data provided by the devices, the system can generate real-timedisplays and maps of asthma inhaler use for review by authorized users,including but not limited to patients, family members, health careproviders or insurers, pharmaceutical companies, public health agencies,and scientific researchers, among others.

The system performs statistical analyses to automatically identifypotentially important changes in the patient's immediate condition,impairment, trends over time, and future risk.

The device and system delivers information to authorized users aboutmedication use and management that has not previously been available.This includes customizable alerts about individuals or aggregate usage.

By coordinating and aggregating data from the multitude of devices usedby individuals, the device and system offers a means to conductstatistical analyses to automatically identify spatiotemporal clustersand temporal aberrations among the population (or specific geographic ordemographic groups within the population) using the device.

The system combines data from medication usage patterns of individualpatients to generate objective and real-time knowledge about disease inthe community, a unit of analysis that has not previously beenavailable. This includes data about the burden of disease and managementpractices, with respect to demographic groups or geographic areas ofinterest that would not be otherwise available.

The system offers aggregated information about the spatial and temporalpatterns of medication use that can be used by public health andenvironmental health agencies to develop or evaluate surveillanceactivities or related clinical or public health interventions.

The device is easily adaptable to the existing variety of medicationinhalers and to other medications or medical devices, including thosefor routine use and those for use as needed to relieve symptoms. In thisway, the device can be used to monitor and indicate where and whenpeople use or do not use preventive medications and thus allow deliveryof location and time specific contextual reminders to enhancecompliance, something that has never before been possible.

The device and method provides a variety of online tools to facilitatedisease management by patients and their health care providers. Thesetools can be readily updated to incorporate the recommendations ofclinical practice guidelines, and are easily adaptable to userpreferences.

Other objects and advantages regarding the device and method/systeminclude the ability to alert patients, providers and public healthagencies to potentially significant events only when they occur,minimizing the time and effort required to routinely review data forimportant events.

These alerts represent a significant improvement because they can bebased on pre-set algorithms, customized parameters, ongoing statisticalanalysis, or some combination of these techniques.

In addition, the described device is durable and can be manufactured andsold for a low cost, representing a considerable improvement overdevices described in the prior art. The described device also has lowpower requirements and the power supply 205 only infrequently needs tobe recharged or replaced. Moreover, the device is inexpensive, rugged,and has virtually no moving parts.

Further, the device has a small size, low-profile, and discreteoperation, thereby improving patient acceptance since it can be usedwithout drawing unwanted attention to the patient or inhaler, and ismore likely to be carried and used as normal, compared to devicesdescribed in the prior art which add to the size and weight of theinhaler.

The device also represents a technical improvement over devicesdescribed in the prior art that rely solely on a global positioningreceiver. The device can, by means of the wireless communicationnetwork, the network computer system, or the terminal device withinherent handset-based and/or network-based location techniques,determine geographic coordinates when indoors and when in urban areaswhere satellite reception may be limited by buildings.

Further, for the same reasons, the device and system can determinegeographic coordinates in a short time period, since it can usecontinually-updated location information from the terminal device or thewireless communication network or the network computer system.

Further objects and advantages of the invention will become apparentfrom consideration of the drawings and ensuing description.

Furthermore, other areas of art may benefit from this method andadjustments to the design are anticipated. Thus, the scope of theinvention should be determined by the appended claims and their legalequivalents, rather than by the examples given.

1. (canceled)
 2. An inhaler monitoring system comprising: a medicamentdevice configured to removably mount to an exterior surface of a metereddose inhaler, wherein the medicament device comprises: a switchmechanism configured to close an electrical circuit in response to anactuation of the metered dose inhaler to dispense medication, theclosing of the electrical circuit causing the transmission of anelectrical signal representing the dispensing of the medication; acommunication device configured to receive the electrical signaltransmitted by the switch mechanism; and a processor and memory storinginstructions that, when executed by the processor, cause the processorto: record the actuation of the metered dose inhaler as an inhaler usageevent; determine a time and date of the recorded inhaler usage event;transmit the determined time and data via the communication device; anda non-transitory computer readable storage medium storing instructionsencoded thereon that, when executed by a processor of a terminal device,cause the processor of the terminal device to: receive the transmittedtime and date of the recorded inhaler usage event; and update a recordof inhaler usage by the patient with the received time and date.
 3. Theinhaler monitoring system of claim 2, wherein the switch mechanism isconfigured to removably mount to a medicament canister of the metereddose inhaler at an exposed end of the medicament canister and thecommunication device and the processor are integrated into a medicamentpackage configured to removably mount to a side of the metered doseinhaler.
 4. The inhaler monitoring system of claim 3, wherein the switchmechanism, the communication device, and the processor are integratedinto a medicament package configured to removably mount to the side ofthe metered dose inhaler.
 5. The inhaler monitoring system of claim 3,wherein the switch mechanism, the communication device, and theprocessor are integrated into a medicament packaged configured toremovably mount to the exposed end of the medicament canister.
 6. Theinhaler monitoring system of claim 3, wherein the switch mechanism isconfigured to mechanically depress in response to a downward movement ofthe medicament canister, the mechanical depression representing thedepression of the medication.
 7. The inhaler monitoring system of claim3, wherein the switch mechanism comprises an optical sensor thatmonitors a tag or a label mounted to the medicament canister, theoptical sensor recording a pattern of optical sensor imagescharacterizing actuations of the metered dose inhaler.
 8. The inhalermonitoring system of claim 3, wherein the switch mechanism comprises: alever extending out of the side of the metered dose inhaler into an areaabove the exposed end of the medicament canister; and a cap removablymounted to the exposed end of the medicament canister, wherein actuationof the medicament canister causes the cap to contact the lever, thecontact representing the dispensing of the medication.
 9. The inhalermonitoring system of claim 8, wherein the lever extends internallythrough the metered dose inhaler and is configured to move when themedicament canister is actuated downwards, the movement of the leveractivating a micro-switch to communicate a signal representing thedispensing of the medication.
 10. The inhaler monitoring system of claim2, wherein the medicament device is removably mounted to the metereddose inhaler by one of the following: a grip mechanism; a snap-fitmechanism; a strap; a clamp; and adhesive fixing.
 11. The inhalermonitoring system of claim 2, wherein the switch mechanism is athermistor configured to measure a change in temperature of the metereddose inhaler resulting from a dispensing of the medication, the changein temperature causing the transmission of a signal representing thedispensing of the medication.
 12. The inhaler monitoring system of claim2, wherein the switch mechanism comprises: a magnet removably mounted tothe exterior surface of the metered dose inhaler; and a magnetic fieldsensor integrated into a body of the metered dose inhaler; wherein themagnetic field sensor is configured to record a change in voltage outputin the sensor when actuation of the metered dose inhaler moves themagnet in proximity to the magnetic field sensor.
 13. The inhalermonitoring system of claim 2, wherein the communication device isfurther configured to receive information from the terminal device. 14.The inhaler monitoring system of claim 2, wherein the terminal device isa mobile device operated by one of the following: a user actuating themetered dose inhaler to dispense the medication; and a healthprofessional associated with a user actuating the metered dose inhaler.15. An inhaler monitoring system comprising: A metered dose inhalerconfigured to dispense medication when actuated by a user; a medicamentdevice configured to removably mount to an exterior surface of themetered dose inhaler, wherein the medicament device comprises: a switchmechanism configured to close an electrical circuit in response to anactuation of the metered dose inhaler to dispense medication, theclosing of the electrical circuit causing the transmission of anelectrical signal representing the dispensing of the medication; acommunication device configured to receive the electrical signaltransmitted by the switch mechanism; and a processor and memory storinginstructions that, when executed by the processor, cause the processorto: record the actuation of the medicament canister as an inhaler usageevent; determine a time and date of the recorded inhaler usage event;transmit the determined time and data via the communication device; anda non-transitory computer readable storage medium storing instructionsencoded thereon that, when executed by a processor of a terminal device,cause the processor of the terminal device to: receive the transmittedtime and date of the recorded inhaler usage event; and update a recordof inhaler usage by the patient with the received time and date.
 16. Theinhaler monitoring system of claim 15, wherein the switch mechanism isconfigured to removably mount to an medicament canister of the metereddose inhaler at an exposed end of the medicament canister and thecommunication device and the processor are integrated into a medicamentpackage configured to removably mount to a side of the metered doseinhaler.
 17. The inhaler monitoring system of claim 16, wherein theswitch mechanism is configured to mechanically depress in response to adownward movement of the medicament canister, the mechanical depressionrepresenting the depression of the medication.
 18. The inhalermonitoring system of claim 15, wherein the switch mechanism comprises: amagnet removably mounted to the exterior surface of the metered doseinhaler; and a magnetic field sensor integrated into a body of themetered dose inhaler; wherein the magnetic field sensor is configured torecord a change in voltage output in the sensor when actuation of themetered dose inhaler moves the magnet in proximity to the magnetic fieldsensor.
 19. An inhaler monitoring system comprising: monitoring meansfor removably mounting to an exterior surface of a metered dose inhaler,wherein the monitoring means comprises: switching means for closing anelectrical circuit in response to an actuation of the metered doseinhaler to dispense medication, the closing of the electrical circuitcausing the transmission of an electrical signal representing thedispensing of the medication; communicating means for receiving theelectrical signal transmitted by the switch mechanism, recording theactuation of the metered dose inhaler as an inhaler usage event,determining a time and date of the recorded inhaler usage event, andtransmitting the determined time and data; and receiving means forreceiving the transmitted time and date of the recorded inhaler usageevent, and updating a record of inhaler usage by the patient with thereceived time and date.
 20. The inhaler monitoring system of claim 19,wherein the switching means is configured to removably mount to amedicament canister of the metered dose inhaler at an exposed end of themedicament canister and the communicating means is integrated into amedicament package configured to removably mount to a side of themetered dose inhaler.
 21. The inhaler monitoring system of claim 20,wherein the switching means is configured to mechanically depress inresponse to a downward movement of the medicament canister, themechanical depression representing the depression of the medication.